FLudrocortisone Administration in Aneurysmal Subarachnoid Haemorrhage

NCT06409364 | Recruiting Phase 2 DMC

• 2 other identifiers: TGI-CCP-352742030936
• Study Type: interventional
• Target: 524
• Locations: 2 countries
• Sites: 16

Brief Summary

A multi-centre, prospective, blinded, randomised clinical trial of fludrocortisone compared with placebo in patients presenting with aneurysmal subarachnoid haemorrhage. The study aim is to determine if early administration of enteral fludrocortisone in aneurysmal subarachnoid haemorrhage reduce death and dependency at six months.

Conditions

Aneurysmal Subarachnoid Hemorrhage

Keywords

aSAH

Outcome Measures

Primary Outcomes (1)

• Modified Rankin Scale

  The primary outcome measure will be the modified Rankin Scale (mRS) score. Scores range from 0-5 with 0 is no disability and 5 is severe.

  Six months after randomisation

Secondary Outcomes (1)

• Subarachnoid Haemorrhage Outcome Tool (SAHOT)

  Six months after randomisation

Other Outcomes (13)

• mortality

  90 days

• Major disability or death (Modified Rankin Score (mRS) or >=3)

  90 days

• Days alive and free of ICU

  90 days

Study Arms (2)

Study drug

EXPERIMENTAL

Fludrocortisone Acetate 100ug Q6 hourly, given enterally for 14 days

Drug: Fludrocortisone

Placebo

PLACEBO COMPARATOR

Matched placebo tablet Q6 hourly, given enterally for 14 days

Drug: Placebo

Interventions

Fludrocortisone DRUG

small white tablet containing 100mcg of fludrocortsone

Also known as: Flurinef

Study drug

Placebo DRUG

Matched placebo tablet,

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Diagnosed with subarachnoid haemorrhage from an aneurysm confirmed on computed tomography angiography (CTA) or digital subtraction angiography (DSA) of the intra-cranial arteries
• Aneurysm has been secured
• Hospital admission for aSAH within 96 hours
• Currently being treated in a critical care environment

You may not qualify if:

• Unable to receive enteral medications
• Pre-existing glucocorticoid or mineralocorticoid treatment
• Previous allergic reaction to fludrocortisone
• History of cardiac, hepatic, or renal failure
• Hypernatremia or hyponatremia (Na\>145mmol/L or Na\<125mmol/L) on the most recent blood sample at the time of screening.
• Death deemed imminent or inevitable
• Pregnancy (confirmed or suspected)

Sponsors & Collaborators

• The George Institute: lead

Study Sites (16)

John Hunter Hospital

New Lambton Heights, New South Wales, 2042, Australia

NOT YET RECRUITING

Nepean Hospital

Penrith, New South Wales, 2747, Australia

RECRUITING

Prince of Wales Hospital

Randwick, New South Wales, 2031, Australia

NOT YET RECRUITING

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

NOT YET RECRUITING

Westmead Hospital

Westmead, New South Wales, 2145, Australia

NOT YET RECRUITING

Wollongong Hospital

Wollongong, New South Wales, 2521, Australia

NOT YET RECRUITING

Royal Brisbane Women's Hospital

Brisbane, Queensland, 4029, Australia

NOT YET RECRUITING

Gold Coast University Hospital

Gold Coast, Queensland, 4215, Australia

RECRUITING

Townsville Hospital

Townsville, Queensland, 4814, Australia

NOT YET RECRUITING

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

NOT YET RECRUITING

Royal Hobart Hospital

Hobart, Tasmania, 7000, Australia

NOT YET RECRUITING

Monash Medical Centre

Clayton, Victoria, 3168, Australia

NOT YET RECRUITING

St Vincent's Hospital (Melbourne)

Fitzroy, Victoria, 3065, Australia

NOT YET RECRUITING

The Alfred Hospital

Melbourne, Victoria, 3044, Australia

NOT YET RECRUITING

Auckland City Hospital

Auckland, 1023, New Zealand

NOT YET RECRUITING

Wellington Hospital

Wellington, 6011, New Zealand

NOT YET RECRUITING

Related Publications (1)

• Cohen J, Delaney A, Udy A, Andersen C, Anderson CS, Bellapart J, Burrell LM, Devaux A, Evans DM, Fitzgerald E, Garside T, Hammond N, Hardie M, Jeffree RL, Knowles S, Lassig-Smith M, Li Q, Nethathe G, Rajbhandari D, Ramanan M, Talbot P, Taylor C, Wright J, Young MJ, Young PJ, Venkatesh B. Fludrocortisone to treat patients with aneurysmal subarachnoid haemorrhage: Protocol for an international, phase 3, randomised, placebo-controlled, multicentre trial. Crit Care Resusc. 2025 Jun 30;27(2):100116. doi: 10.1016/j.ccrj.2025.100116. eCollection 2025 Jun.

  PMID: 40677678 DERIVED

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Interventions

Fludrocortisone

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydrocortisone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Jeremy Cohen, MBBS

  Royal Brisbane Hospital, Brisbane, Australia

  PRINCIPAL INVESTIGATOR

• Anthony Delaney, MBBS

  Royal North Shore Hospital, Sydney, Australia

  PRINCIPAL INVESTIGATOR

• Torg Westerlund, MBBS

  John Hunter Hospital, Newcastle, Australia

  PRINCIPAL INVESTIGATOR

• Andrew Udy, BHB MB ChB

  The Alfred Hospital, Melbourne, Australia

  PRINCIPAL INVESTIGATOR

• Alex Nesbitt, MBBS

  Princess Alexandra Hospital

  PRINCIPAL INVESTIGATOR

• Ian Sepppelt, MBBS

  Nepean Blue Mountains Local Health District

  PRINCIPAL INVESTIGATOR

• Mak Wei-Yun, MBBS

  Monash Medical Centre

  PRINCIPAL INVESTIGATOR

• David Bowen, MBBS

  Westmead Hospital

  PRINCIPAL INVESTIGATOR

• James McCulloch, MBChB

  Gold Coast University Hospital

  PRINCIPAL INVESTIGATOR

• Humphrey Walker, MBBS

  St Vincent's Hospital Melbourne

  PRINCIPAL INVESTIGATOR

• Sananta Dash, MBBS

  Townsville University Hospital

  PRINCIPAL INVESTIGATOR

• Matthew MacPartlin, MBBS

  Wollongong Hospital

  PRINCIPAL INVESTIGATOR

• Andrew Turner, MBBS

  Royal Hobart Hospital

  PRINCIPAL INVESTIGATOR

• Gavin Salt, MBBS

  Prince of Wales Hospital

  PRINCIPAL INVESTIGATOR

• Laura Tincknell, MBBS

  Auckland City Hospital

  PRINCIPAL INVESTIGATOR

• Jason Wright, MBBS

  Wellington City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeremy Cohen, MBBS

CONTACT

+610732327000; cohenjeremy@me.com

Dorrilyn Rajbhandari, BN

CONTACT

drajbhandari@georgeinstitute.org.au

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinded participant, care provider, investigator and outcome assessors. Study drug and placebo identical in appearance.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A multi-centre, prospective, blinded, randomised clinical trial of fludrocortisone compared with placebo in patients presenting with aneurysmal subarachnoid haemorrhage.

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 10, 2024
• Study Start: August 13, 2025
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): July 31, 2030
• Last Updated: December 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

AU (14); NZ (2)